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Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Primary Purpose

Smoking Cessation, Tobacco Dependence

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Counseling and Support Materials
Laboratory Assessments
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation focused on measuring pharmacotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥18 years of age
  • Smoke at least 10 cigarettes daily for the past year
  • Expired-air carbon monoxide (CO) > 8 ppm
  • Medically eligible to receive varenicline
  • Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking.

Exclusion Criteria:

  • Are pregnant or lactating
  • Have renal dysfunction
  • Have a history of seizures
  • Are medically at risk in the judgment of the study physician
  • Have ever used varenicline
  • Have used other smoking cessation medications within the past three months
  • Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders)
  • Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015).
  • We must limit the number of participants from the same street address to 1.

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Extended Varenicline + Facilitated Extinction

Standard Varenicline (SV)

Extended Varenicline (EV)

Arm Description

Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.

Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.

Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.

Outcomes

Primary Outcome Measures

Rate of Participant Retention
Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).

Secondary Outcome Measures

Client Satisfaction Questionnaire (CSQ) Results
Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.
Rate of Intervention Adherence - Medication
Percent of participants still using varenicline at time of analysis.
Average Intervention Adherence - Cigarettes Per Day (CPD)
Average Cigarettes per Day across group, during last week of treatment.
Mean Peak Craving Score Per Group
Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was "none", 5 "medium" and 10 "very high/strong"
Mean Smoking Satisfaction Score Per Group
Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"

Full Information

First Posted
July 22, 2014
Last Updated
November 24, 2020
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
James and Esther King Biomedical Research Program, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02202499
Brief Title
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
Official Title
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2014 (Actual)
Primary Completion Date
December 11, 2015 (Actual)
Study Completion Date
June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
James and Esther King Biomedical Research Program, Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.
Detailed Description
Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session. Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Tobacco Dependence
Keywords
pharmacotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Varenicline + Facilitated Extinction
Arm Type
Active Comparator
Arm Description
Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.
Arm Title
Standard Varenicline (SV)
Arm Type
Active Comparator
Arm Description
Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
Arm Title
Extended Varenicline (EV)
Arm Type
Active Comparator
Arm Description
Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix™
Intervention Description
All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.
Intervention Type
Other
Intervention Name(s)
Counseling and Support Materials
Intervention Description
Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
Intervention Type
Other
Intervention Name(s)
Laboratory Assessments
Intervention Description
The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
Primary Outcome Measure Information:
Title
Rate of Participant Retention
Description
Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).
Time Frame
End of post treatment follow-up period of 3 months - approximately 28 weeks
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ) Results
Description
Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.
Time Frame
One month post treatment - approximately 20 weeks
Title
Rate of Intervention Adherence - Medication
Description
Percent of participants still using varenicline at time of analysis.
Time Frame
One month post treatment - approximately 20 weeks
Title
Average Intervention Adherence - Cigarettes Per Day (CPD)
Description
Average Cigarettes per Day across group, during last week of treatment.
Time Frame
During last week of treatment, week 16
Title
Mean Peak Craving Score Per Group
Description
Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was "none", 5 "medium" and 10 "very high/strong"
Time Frame
Across 4 pre-quit weeks
Title
Mean Smoking Satisfaction Score Per Group
Description
Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"
Time Frame
Across 4 pre-quit weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥18 years of age Smoke at least 10 cigarettes daily for the past year Expired-air carbon monoxide (CO) > 8 ppm Medically eligible to receive varenicline Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking. Exclusion Criteria: Are pregnant or lactating Have renal dysfunction Have a history of seizures Are medically at risk in the judgment of the study physician Have ever used varenicline Have used other smoking cessation medications within the past three months Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders) Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015). We must limit the number of participants from the same street address to 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Brandon, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

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